Buyer beware: The story of a pricey and “credentialled” program to end Alzheimer’s Disease

After decades of research, Bre­desen had con­clud­ed that more than 36 dri­vers of Alzheimer’s cumu­la­tive­ly con­tribute to the loss of men­tal acu­ity. They range from chron­ic con­di­tions like heart dis­ease and dia­betes to vit­a­min and hor­mon­al defi­cien­cies, undi­ag­nosed infec­tions and even long-term expo­sures to tox­ic sub­stances. Bredesen’s impres­sive aca­d­e­m­ic cre­den­tials lent legit­i­ma­cy to his approach.

Pan paid $4,000 to a doc­tor trained in Bredesen’s pro­gram for a con­sul­ta­tion and a series of exten­sive lab­o­ra­to­ry tests, then was referred to anoth­er doc­tor, who devised a strin­gent reg­i­men of dietary changes that entailed cut­ting out all sug­ars, eat­ing a high-fat, low-car­bo­hy­drate diet and adher­ing to a com­plex reg­i­men of med­i­ta­tion, vig­or­ous dai­ly exer­cise and about a dozen nutri­tion­al sup­ple­ments each day (at about $200 a month). Pan said she had exten­sive mold reme­di­a­tion done in her home after the Bre­desen doc­tors told her the sub­stance could be hurt­ing her husband’s brain.

But two years passed, she said, and her hus­band, Wayne, was steadi­ly declin­ing. To make mat­ters worse, he had lost more than 60 pounds because he didn’t like the food on the diet. In April, he died.

“I imag­ine it works in some peo­ple and doesn’t work in oth­ers,” said Pan, who lives in Oak­ton, Vir­ginia. “But there’s no way to tell ahead of time if it will work for you.”

Bre­desen wrote the best-sell­ing 2017 book “The End of Alzheimer’s” and has pro­mot­ed his ideas in talks to com­mu­ni­ty groups around the coun­try and in radio and TV appear­ances like “The Dr. Oz Show.” He has also start­ed his own com­pa­ny, Apol­lo Health, to mar­ket his pro­gram and train and pro­vide refer­rals for practitioners.

Unlike oth­er self-help reg­i­mens, Bre­desen said, his pro­gram is an intense­ly per­son­al­ized and sci­en­tif­ic approach to coun­ter­act each individual’s spe­cif­ic deficits by “opti­miz­ing the phys­i­cal body and under­stand­ing the mol­e­c­u­lar dri­vers of the dis­ease,” he told KHN in a Novem­ber phone inter­view. “The vast major­i­ty of peo­ple improve” as long as they adhere to the regimen.

Bredesen’s peers acknowl­edge him as an expert on aging. A for­mer post­doc­tor­al fel­low under Nobel lau­re­ate Stan­ley Prusin­er at the Uni­ver­si­ty of Cal­i­for­nia-San Fran­cis­co, Bre­desen presided over a well-fund­ed lab at UCLA for more than five years. He has been on the UCLA fac­ul­ty since 1989 and also found­ed the Buck Insti­tute for Research on Aging in Marin Coun­ty. He has writ­ten or co-authored more than 200 papers.

But col­leagues are crit­i­cal of what they see as his com­mer­cial pro­mo­tion of a large­ly unproven and cost­ly reg­i­men. They say he strays from long-estab­lished sci­en­tif­ic norms by rely­ing on anec­do­tal reports from patients, rather than pro­vid­ing evi­dence with rig­or­ous research.

“He’s an excep­tion­al sci­en­tist,” said George Per­ry, a neu­ro­sci­en­tist at the Uni­ver­si­ty of Texas-San Anto­nio. “But mon­e­tiz­ing this is a turnoff.”

“I have seen des­per­ate patients and fam­i­ly mem­bers clean out their bank accounts and believe this will help them with every ounce of their being,” said Dr. Joan­na Hell­muth, a neu­rol­o­gist in the Mem­o­ry and Aging Cen­ter at UCSF. “They are cling­ing to hope.”

Many of the lifestyle changes Bre­desen pro­motes are known to be help­ful. “The pro­to­col itself is based on very low-qual­i­ty data, and I wor­ry that vul­ner­a­ble patients and fam­i­ly mem­bers may not under­stand that,” said Hell­muth. “He trained here” — at UCSF — “so he knows better.”

The Bre­desen pack­age doesn’t come cheap. He has built a net­work of prac­ti­tion­er-fol­low­ers by train­ing them in his pro­to­col — at $1,800 a pop — in sem­i­nars spon­sored by the Insti­tute for Func­tion­al Med­i­cine, which empha­sizes alter­na­tive approach­es to man­ag­ing dis­ease. Apol­lo Health also offers two-week train­ing ses­sions for a $1,500 fee.

Once trained in his ReCODE Pro­to­col, med­ical pro­fes­sion­als charge patients upward of $300 for a con­sul­ta­tion and as much as $10,500 for eight- to 15-month treat­ment pack­ages. For the ReCODE pro­to­col, aimed at peo­ple already suf­fer­ing from ear­ly-stage Alzheimer’s dis­ease or mild cog­ni­tive decline, Apol­lo Health charges an ini­tial $1,399 fee for a refer­ral to a local prac­ti­tion­er that includes an assess­ment and exten­sive lab­o­ra­to­ry tests. Apol­lo then offers $75-per-month sub­scrip­tions that pro­vide cog­ni­tive games and online sup­port, and links to anoth­er com­pa­ny that offers dietary sup­ple­ments for an addi­tion­al $150 to $450 a month. Insur­ance gen­er­al­ly cov­ers lit­tle of these costs.

Apol­lo Health, found­ed in 1998 and head­quar­tered in Burlingame, Cal­i­for­nia, also offers a pro­to­col geared toward those who have a fam­i­ly his­to­ry of demen­tia or want to pre­vent cog­ni­tive decline.

Bre­desen esti­mates that about 5,000 peo­ple have done the ReCODE pro­gram. The fees are a bar­gain, Bre­desen said, if they slow decline enough to pre­vent some­one from being placed in a nurs­ing home, where year­ly costs can climb past $100,000 annually.

Bre­desen and his com­pa­ny are tap­ping into the des­per­a­tion that has grown out of the fail­ure of a decades-long sci­en­tif­ic quest for effec­tive Alzheimer’s treat­ments. Much of the research mon­ey in the field has nar­row­ly focused on amy­loid — the bar­na­cle-like gunk that col­lects out­side nerve cells and inter­feres with the brain’s sig­nal­ing sys­tem — as the main cul­prits behind cog­ni­tive decline. Drug­mak­ers have tried repeat­ed­ly, and thus far with­out much suc­cess, to invent a tril­lion-dol­lar anti-amy­loid drug. There’s been less empha­sis in the field on the lifestyle choic­es that Bre­desen stresses.

“Amy­loids sucked up all the air in the room,” said Dr. Lon Schnei­der, an Alzheimer’s researcher and a pro­fes­sor of psy­chi­a­try and behav­ioral sci­ences at the Keck School of Med­i­cine at USC.

Grow­ing evi­dence shows lifestyle changes help delay the progress of the mind-rob­bing dis­ease. An exhaus­tive Lancet report in August iden­ti­fied a long list of risk fac­tors for demen­tia, includ­ing exces­sive drink­ing, expo­sure to air pol­lu­tion, obe­si­ty, loss of hear­ing, smok­ing, depres­sion, lack of exer­cise and social iso­la­tion. Con­trol­ling these fac­tors — which can be done on the cheap — could delay or even pre­vent up to 40% of demen­tia cas­es, accord­ing to the report.

Bredesen’s pro­gram involves all these prac­tices, with per­son­al­ized bells and whis­tles like inter­mit­tent fast­ing, med­i­ta­tion and sup­ple­ments. Bredesen’s sci­en­tif­ic peers ques­tion whether data sup­ports his micro­man­aged approach over plain-vanil­la healthy living.

Bre­desen has pub­lished three papers show­ing pos­i­tive results in many patients fol­low­ing his approach, but crit­ics say he has fall­en short of prov­ing his method’s effectiveness.

The papers lack details on which pro­to­col ele­ments were fol­lowed, or the treat­ment dura­tion, UCSF’s Hell­muth said. Nor do they explain how cog­ni­tive tests were con­duct­ed or eval­u­at­ed, so it’s dif­fi­cult to gauge whether improve­ments were due to the inter­ven­tion, to chance vari­a­tions in per­for­mance or an assort­ment of oth­er vari­ables, she said.

Bre­desen shrugs off the crit­i­cism: “We want things to be in an open-access jour­nal so every­body can read it. These are still peer-reviewed jour­nals. So what’s the problem?”

Anoth­er prob­lem raised about Bredesen’s enter­prise is the lack of qual­i­ty con­trol, which he acknowl­edges. Apol­lo-trained “cer­ti­fied prac­ti­tion­ers” can include every­one from nurs­es and dieti­tians to chi­ro­prac­tors and health coach­es. Prac­ti­tion­ers with vary­ing degrees of train­ing and com­pe­tence can take his class­es and hang out a shin­gle. That’s a painful fact for some who buy the package.

“I had the impres­sion these prac­ti­tion­ers were cer­ti­fied, but I real­ize they all had just tak­en a two-week course,” said a Vir­ginia man who request­ed anonymi­ty to pro­tect his wife’s pri­va­cy. He said that he had spent more than $15,000 on tests and treat­ments for his ail­ing spouse and that six months into the pro­gram, ear­li­er this year, she had failed to improve.

Bre­desen said he and his staff were review­ing “who’s get­ting the best results and who’s get­ting the worst results,” and intend­ed to cut poor per­form­ers out of the net­work. “We’ll make it so that you can only see the peo­ple get­ting the best results,” he said.

Col­leagues say that to test whether Bredesen’s method works it needs to be sub­ject­ed to a place­bo-con­trolled study, the gold stan­dard of med­ical research, in which half the par­tic­i­pants get the treat­ment while the oth­er half don’t.

In the absence of rig­or­ous stud­ies, said USC’s Schnei­der, a co-author of the Lancet report, “say­ing you can ‘end Alzheimer’s now and this is how you do it’ is over­promis­ing and over­sim­pli­fy­ing. And a lot of it is just com­mon sense.”

Bre­desen no longer says his method can end Alzheimer’s, despite the title of his book. Apol­lo Health’s web­site still makes that claim, however.

– By Lin­da Marsa. This sto­ry was pro­duced by KHN, which pub­lish­es Cal­i­for­nia Health­line, an edi­to­ri­al­ly inde­pen­dent ser­vice of the Cal­i­for­nia Health Care Foun­da­tion. 

News in Context:

• Brain scans show low­er accu­mu­la­tion of tau and amy­loid pathol­o­gy among cog­ni­tive “super-agers”
• Cog­ni­tive train­ing, diet, exer­cise, and vas­cu­lar man­age­ment seen to improve cog­ni­tion even in peo­ple with genet­ic pre­dis­po­si­tion for demen­tia (APOE e4)
• Report: 35% of world­wide demen­tia cas­es could be pre­vent­ed by mod­i­fy­ing these 9 mod­i­fi­able risk factors
• Solv­ing the Brain Fit­ness Puz­zle Is the Key to Self-Empow­ered Aging
• Build Your Cog­ni­tive Reserve: Inter­view with Yaakov Stern